Coronavirus: Medsafe approves Pfizer-BioNTech COVID-19 vaccine for children, ball now in Cabinet's court

Medsafe has approved the Pfizer-BioNTech vaccine for children, the regulatory agency announced on Thursday. 

Kiwi kids under 12 will get an adapted version of the existing vaccine for the 12-plus age group, group manager Chris James said.

"The Medsafe team has worked tirelessly this year to ensure that COVID-19 vaccine applications are prioritised and urgently reviewed, while still maintaining the same scrutiny that all medicine applications undergo before they can be approved.

"Medsafe will only approve a vaccine or medicine for use in New Zealand once it is satisfied that it has met high standards for quality, safety and efficacy."

The provisional approval is for two paediatric doses given at least 21 days apart.

The exact date the rollout will begin will depend on Cabinet, which is yet to give its approval, but expected to be by the end of January.

"Medsafe approval is the first step in the process, and the COVID-19 Vaccine Technical Advisory Group is now providing advice to the Ministry of Health to inform Cabinet’s decision whether to use the vaccine in New Zealand," said Astrid Koornneef, the Ministry of Health's national immunisation programme director.

"If Cabinet agrees to use the vaccine in New Zealand, we want to have systems in place to roll out the vaccine safely and efficiently, at the earliest opportunity. This means completing the necessary training and working with the community to roll out the vaccine, including through whānau-based approaches."

A number of countries are already vaccinating children under 12, including the US, France, Germany, Greece, Italy, Bahrain, Israel, Saudi Arabia, China, Indonesia, Cuba, Venezuela, Argentina and Canada. Not all are using mRNA-based vaccines like that made by Pfizer-BioNTech.